Prescribing Information

Duavee (conjugated estrogens/bazedoxifene) contains a form of the female hormone, estrogen, along with an estrogen agonist/antagonist used to treat moderate to severe vasomotor symptoms associated with menopause and to prevent postmenopausal osteoporosis in women who still have a uterus. Common side effects include muscle spasms, nausea, diarrhea, indigestion, upper abdominal pain, throat pain, dizziness, and neck pain.

The recommended dosage is one Duavee tablet daily. Duavee may interact with St. John's Wort, phenobarbital, carbamazepine, rifampin, antibiotics, azole antifungals, ritonavir, grapefruit juice, and phenytoin. Tell your doctor all medications and supplements you use. Duavee must not be used in women who are or may become pregnant. It is unknown if this drug is passes into breast milk. Estrogens can decrease the quantity and quality of the milk. Duavee is not recommended for use while breastfeeding.

Our Duavee (conjugated estrogens/bazedoxifene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

The safety of conjugated estrogens/bazedoxifene was
evaluated in four Phase 3 clinical trials ranging from 12 weeks to 24 months in
duration and enrolling 6,210 postmenopausal women age 40 to 75 years (mean age
55 years). A total of 1,224 patients were treated with DUAVEE and 1,069
patients received placebo. Women enrolled in Studies 1 and 2 received calcium
(600-1200 mg) and vitamin D (200-400 IU) daily, while women in Studies 3 and 4
received no calcium and vitamin D supplementation as part of the protocol.

The incidence of all-cause mortality was 0.0% in the
DUAVEE group and 0.2% in the placebo group. The incidence of serious adverse
reactions was 3.5% in the DUAVEE group and 4.8% in the placebo group. The
percentage of patients who withdrew from treatment due to adverse reactions was
7.5% in the DUAVEE group and 10.0% in the placebo group. The most common adverse
reactions leading to discontinuation were hot flush, abdominal pain upper, and
nausea.

The most commonly observed adverse reactions (incidence ≥
5%) more frequently reported in women treated with DUAVEE than placebo are
presented in Table 1.

Table 1: Adverse Reactions (Incidence ≥ 5%) More
Common in the DUAVEE Treatment Group in Placebo-controlled Trials

DUAVEE
(N=1224)
n (%)

Placebo
(N=1069)
n (%)

Gastrointestinal disorders

Nausea

100 (8)

58 (5)

Diarrhea

96 (8)

57(5)

Dyspepsia

84 (7)

59 (6)

Abdominal pain upper

81(7)

58 (5)

Musculoskeletal and connective tissue disorders

Muscle spasms

110 (9)

63 (6)

Neck pain

62 (5)

46 (4)

Nervous system disorders

Dizziness

65 (5)

37 (3)

Respiratory, thoracic, and mediastinal disorders

Oropharyngeal pain

80 (7)

61(6)

Venous thromboembolism

In the clinical studies with DUAVEE, the reporting rates
for venous thromboembolism (deep venous thrombosis, pulmonary embolism, and
retinal vein thrombosis) were low in all treatment groups. Adverse reactions of
venous thromboembolism were reported in 0.0% of patients treated with DUAVEE
and 0.1% of patients treated with placebo. Due to the low rate of events in
both groups, it is not possible to conclude that the risk of venous thromboembolism
with DUAVEE is different from that seen with other estrogen therapies [see WARNINGS
AND PRECAUTIONS].